Electrode catheters and methods for making them

ABSTRACT

Catheters, sheaths, or other tubular devices are provided that include a proximal end, a distal end sized for introduction into a patient&#39;s body, and a steerable distal portion carrying a plurality of electrodes. The tubular device includes a primary lumen extending between the proximal and distal ends; a steering element lumen adjacent the primary lumen; a plurality of wires extending proximally from the electrodes, and reinforcement members including windings extending helically along at least the distal portion, at least some of the windings passing between the primary and steering element lumens and wires, and at least some of the windings surrounding the primary lumen and one or both of the steering element lumen and the wires. In one embodiment, a steering element is slidably disposed within the auxiliary lumen. Apparatus and methods for making such tubular devices are also provided.

RELATED APPLICATION DATA

This application is a continuation of application Ser. No. 14/738,628,filed Jun. 12, 2015, issuing as U.S. Pat. No. 10,071,222, which is acontinuation of International application No. PCT/US2015/030043, filedMay 8, 2015, which claims benefit of provisional application Ser. No.61/990,116, filed May 8, 2014, and is a continuation-in-part ofapplication Ser. No. 14/215,060, filed Mar. 17, 2014, now U.S. Pat. No.9,427,551, which claims benefit of provisional application Ser. No.61/802,490, filed Mar. 16, 2013, 61/917,334, filed Dec. 17, 2013, and61/930,672, filed Jan. 23, 2014, the entire disclosures of which areexpressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates generally to reinforced catheters,sheaths, or other tubular devices including multiple lumens, and, moreparticularly, to steerable catheters, sheaths, or other tubular devicesincluding electrodes and/or sensing elements and braided or otherreinforcement configurations to enhance support of a steerable portionof the tubular devices, and to methods for making such tubular devices.

BACKGROUND

Elongate tubular devices, such as diagnostic or treatment catheters orsheaths may be provided for introduction into a patient's body, e.g.,the patient's vasculature or other body lumens. For example, a cathetermay have a distal portion configured to be introduced into a body lumenand advanced to one or more desired locations within the patient's bodyby manipulating a proximal end of the catheter.

To facilitate introduction of such a catheter, one or more wires,cables, or other steering elements may be provided within the catheter,e.g., that are coupled to the distal portion and may be pulled oradvanced from the proximal end to deflect the distal portion. Forexample, a steering element may be provided that is intended to deflectthe distal portion within a predetermined plane and/or into a desiredcurved shape.

Pull wires are a common way to impart deflection ability to such acatheter. However, there are a number of drawbacks associated with suchpull wires. For example, a pull wire occupies a significant amount ofspace within the catheter body. In addition, a pull wire frequentlyneeds to be reinforced, e.g., on the inside and outside of the braid orother reinforcement of the catheter, e.g., to prevent “pull through”when the pull wire is actuated by pushing or pulling, i.e., theresulting bending moment may cause the pull wire to separate layers ofor tear at least partially through the wall of catheter, potentiallysplitting the catheter. Further, a pull wire can make the torqueproperties of the catheter non-homogenous, making it difficult orimpossible to torque the catheter when the pull wire is actuated, e.g.,within a tortuous pathway. Further, auxiliary lumens, in particularthose located in the wall of a large bore sheath, are difficult tomanufacture with consistency due to difficulties with alignment, handassembly, and the like.

For many applications, such a catheter may include one or moreelectrodes and/or sensing elements coupled to one or more wires or otherconducting elements that extend along at least a portion of thecatheter. These components, however, may increase the overall size ofthe catheter, e.g., to provide a lumen for the wires, given the need forother lumens in the device, e.g., a primary lumen, pull wire lumen(s),and the like. Further, the material of the wire(s) may not easilyaccommodate bending of the catheter, e.g., when a pull wire is used tosteer the catheter during delivery and/or otherwise during a procedure,and/or the wire(s) may modify the deflection profile of the catheteradversely.

Accordingly, there is a need for improved steerable catheters, sheaths,and other tubular devices and methods of their manufacture.

SUMMARY

The present invention is directed to reinforced catheters, sheaths, orother tubular devices including multiple lumens. More particularly, thepresent invention is directed to steerable catheters, sheaths, or othertubular devices including one or more electrodes and/or sensingelements, conducting elements coupled to such electrodes and/or sensingelements and extending along the tubular device, and/or braided or otherreinforcement configurations that enhance support of a steerable portionof the tubular devices, and/or to methods for making such catheters,sheaths, or other tubular devices.

In accordance with one embodiment, a tubular device is provided, e.g.,for a catheter or sheath, comprising a proximal end and a distal endsized for introduction into a patient's body. The tubular device mayinclude a central lumen extending between the proximal and distal ends;one or more elongate conducting elements extending at least partiallybetween the proximal and distal ends adjacent the central lumen; and oneor more reinforcement members including windings extending helicallyaround the central lumen between the proximal and distal ends. At leastsome of the windings may pass between the central lumen and theconducting element(s) and at least some of the windings surrounding boththe central lumen and the conducting element(s). In addition, one ormore layers may surround the one or more reinforcement members and oneor more electrodes or sensing elements may be provided on the distal endcoupled to the conducting element(s).

In accordance with another embodiment, an apparatus is provided forperforming a procedure within a patient's body that includes a tubularmember including a proximal end, a distal end sized for introductioninto a patient's body, a central axis extending therebetween, and adistal portion extending distally from an intermediate portion to thedistal end; a primary lumen extending between the proximal and distalends and aligned with and/or otherwise surrounding the central axis; asteering element lumen adjacent the primary lumen and offset from thecentral axis; one or more conducting elements extending at leastpartially along the distal portion adjacent the primary lumen, and oneor more reinforcement members including windings extending helicallyalong at least the distal portion. At least some of the windings passbetween the primary lumen and the steering element lumens, at least someof the windings pass between the primary lumen and the one or moreconducting element, and at least some of the windings surround theprimary lumen and one or both of the steering element lumen and the oneor more conducting elements. A steering element may be slidably disposedwithin the steering element lumen and may include a distal end fixed tothe tubular member distal end and a proximal end coupled to an actuatoron the tubular member proximal end such that, actuation of the actuatorapplies axial tension or compression to the steering element, therebycausing the distal portion to bend.

In accordance with still another embodiment, an apparatus is providedfor performing a procedure within a patient's body that includes atubular member including a proximal end, a distal end sized forintroduction into a patient's body, a central axis extendingtherebetween, and a distal portion extending distally from anintermediate portion to the distal end. A primary lumen extends betweenthe proximal and distal ends and aligned with and/or otherwisesurrounding the central axis, an auxiliary lumen and one or more wiresor other conducting elements are disposed adjacent the primary lumen andoffset from the central axis, the auxiliary lumen and conductingelements extending substantially parallel to the primary lumen along thedistal portion. One or more reinforcement members may include windingsextending helically along at least the distal portion, at least some ofthe windings passing between the primary lumen and one or both of theauxiliary lumen and the conducting elements lumens, and at least some ofthe windings surrounding both the primary and auxiliary lumens and theconducting elements.

In one embodiment, the apparatus further includes a steering elementslidably disposed within the auxiliary lumen and including a distal endfixed to the tubular member distal end and a proximal end adjacent theproximal end of the tubular member; and an actuator on the proximal endcoupled to the steering element proximal end such that, actuation of theactuator applies axial tension or compression to the steering element,thereby causing the distal portion to bend.

In addition, the apparatus may also include one or more electrodesand/or sensing elements on the distal portion that are coupled to theone or more conducting elements. For example, the conducting elementsmay include a plurality of wires extending along the distal portion thatare coupled to a plurality of electrodes spaced apart from one anotheron the distal portion. The wires may extend along the distal portion ina non-linear path to accommodate bending of the distal portion, e.g.,when the steering element is actuated. For example, the wires may extendadjacent one another in a generally sinusoidal or other curvilinear pathadjacent the primary lumen, or may extend helically around the primarylumen.

In accordance with yet another embodiment, a method is provided formaking a tubular body that includes directing a primary mandrel along acentral axis of a braiding apparatus such that the primary mandrel issurrounded by a plurality of reinforcement carrying elements; anddirecting one or more conducting elements adjacent to the primarymandrel. One or more reinforcement members from the reinforcementcarrying elements may be wrapped helically around the primary mandrelsuch that some windings of the one or more reinforcement memberssurround the primary mandrel and pass between the primary mandrel andthe one or more conducting elements, and some windings of the one ormore reinforcement members surround both the primary mandrel and the oneor more conducting elements. An outer jacket may be applied around theprimary mandrel and the one or more conducting elements after wrappingthe one or more reinforcement members therearound. The primary mandrelmay be removed to define a primary lumen within the tubular body.

One or more electrodes and/or sensing elements may be mounted on thedistal portion, which may be electrically coupled to the one or moreconducting elements. For example, the conducting elements may include aplurality of wires and the wires may be exposed at desired regions ofthe distal portion, and spot electrodes may be applied on the distalportion at the desired regions and coupled to the wires.

In addition, the method may also include directing a secondary mandreladjacent to the primary mandrel and offset from the central axis. Whenthe reinforcement members are wrapped around the assembly, at least somewindings may pass between the primary mandrel and the secondary mandrel,and some windings of the one or more reinforcement members surround boththe primary mandrel and the secondary mandrel. The secondary mandrel maylater be removed to define an auxiliary lumen within the tubular bodyadjacent the primary lumen, and a pull wire may be introduced into theauxiliary lumen and coupled to the distal end.

In accordance with still another embodiment, a method is provided formaking a tubular body that includes directing a primary mandrel along acentral axis of a braiding apparatus such that the primary mandrel issurrounded by a plurality of reinforcement carrying elements; anddirecting one or more conducting element adjacent to the primarymandrel. One or more reinforcement members may be wrapped from thereinforcement carrying elements helically around the primary mandrelsuch that some windings of the one or more reinforcement memberssurround the primary mandrel and pass between the primary mandrel andthe one or more conducting elements and some windings of the one or morereinforcement members surround both the primary mandrel and the one ormore conducting elements. Optionally, the reinforcement carryingelements may be rotated relative to the primary mandrel while wrappingthe one or more reinforcement members around the primary mandrel,thereby wrapping the one or more conducting elements helically around atleast a portion of the primary mandrel.

Other aspects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments of the invention, inwhich:

FIG. 1A is a perspective view of an exemplary embodiment of a catheter,including multiple lumens extending between proximal and distal endsthereof, and including a steerable distal portion.

FIG. 1B is a cross-sectional view of the catheter of FIG. 1A, takenalong line 1B-1B, showing reinforcement members positioned aroundprimary and auxiliary lumens of the catheter.

FIG. 1C is a detail of the catheter wall of FIG. 1B, showingreinforcement members and an optional liner that surrounds at least aportion of the auxiliary lumen.

FIG. 2 is a cross-sectional view of another embodiment of a catheterincluding a steering lumen extending helically along an intermediateportion of the catheter and axially along a distal portion of thecatheter to provide a steerable distal portion.

FIG. 3 is a cross-sectional view of a catheter including a handle on aproximal end of the catheter and a steering element within an auxiliarylumen of the catheter that exits the auxiliary lumen within the handleand is coupled to an actuator on the handle.

FIG. 4A is a schematic of an exemplary embodiment of an apparatus formaking a reinforced tubular member including multiple lumens supportedby reinforcement members.

FIG. 4B is a front view of an arrangement of horn gears for creating abraided configuration of reinforcement members that may be included inthe apparatus of FIG. 4A.

FIG. 4C is a detail showing reinforcement members being braided around aprimary mandrel and an auxiliary mandrel for defining lumens of thetubular member.

FIG. 4D is a cross-section of the braided mandrels of FIG. 4C, takenalong line 4D-4D.

FIGS. 5A and 5B are cross-sections of alternative embodiments ofsteerable catheters including multiple auxiliary lumens and steeringelements.

FIGS. 6A-6G are details showing alternative cross-sections of auxiliarylumens and steering elements that may be included in the tubular devicesherein.

FIG. 7 is a cross-section of another embodiment of a tubular deviceincluding a non-circular central lumen and an auxiliary lumen nested atleast partially adjacent the central lumen.

FIG. 8 is a detail of a reinforcement-wrapped mandrel assembly includingan auxiliary mandrel including a portion that exits from reinforcementmembers surrounding a primary mandrel.

FIG. 9 is a side view of a distal portion of another exemplaryembodiment of a catheter including a plurality of electrodes spacedapart from one another on the distal portion.

FIG. 10 is a detail of a reinforcement-wrapped mandrel assembly formaking the catheter of FIG. 9, showing a plurality of wires extendingalong a portion of the catheter adjacent a pull wire lumen and braidedinto a plurality of reinforcement members.

FIGS. 11A-11D are details showing a method for braiding a plurality ofwires of a catheter within a plurality reinforcement members andcoupling electrodes to the wires.

FIG. 11E is a cross-sectional view of an intermediate portion of anapparatus showing a wire transitioning to a central lumen of theapparatus.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Turning to the drawings, FIGS. 1A and 1B show an exemplary embodiment ofan apparatus 10 for introduction into a body lumen (not shown), e.g.,for performing a diagnostic and/or therapeutic procedure within apatient's body. In exemplary embodiments, the apparatus 10 may be aguide catheter, a sheath, a procedure catheter, e.g., an imagingcatheter, an ablation and/or mapping catheter, a balloon catheter, orother tubular device sized for introduction into a body lumen, such as avessel within a patient's vasculature, a passage within a patient'sgastrointestinal tract, urogenital tract, reproductive tract,respiratory tract, lymphatic system, and the like (not shown). Inexemplary embodiments, the apparatus 10 may have a length between aboutten and one hundred ten centimeters (10-110 cm), and an outer diameterbetween about four and ten French (4-24 Fr).

Generally, the apparatus 10 is an elongate tubular member including aproximal end 12, a distal end 14 sized for insertion into a body lumen,a central longitudinal axis 16 extending between the proximal and distalends 12, 14, and one or more lumens 18 extending between the proximaland distal ends 12, 14. For example, as shown in FIG. 1B, the apparatus10 may include a central or primary lumen 18 a, e.g., sized forreceiving or carrying one or more instruments or other elements (notshown) therethrough. In exemplary embodiments, the central lumen 18 amay be sized for receiving or carrying a guide wire, procedure catheter,balloon catheter, ablation catheter, cardiac lead, needle, or otherinstrument (not shown), one or more wires or other conductors, one ormore optical fibers, one or more tubes or accessory lumens, one or moremechanical elements, one or more sensors, and/or sized for deliveringand/or removing fluids or other flowable agents or materialstherethrough.

In one embodiment, shown in FIG. 1A, the central lumen 18 a may exit ator communicate with an outlet 17 in the distal end 14, e.g., to allow aguidewire or other instrument (not shown) to pass therethrough and/orfor delivering or aspirating fluid therethrough. In an alternativeembodiment, such as the apparatus 110 shown in FIG. 2, the central lumen118 a may be enclosed, e.g., terminating within or adjacent the distalend 114, e.g., to isolate the central lumen 118 a and/or elementscarried therein from the environment outside the apparatus 110. In anexemplary embodiment where the apparatus 110 is an ablation and/ormapping catheter, the central lumen 118 a may carry one or more wires orother conductors, thermocouple wires, tubes, and the like (not shown),e.g., coupled to electrodes or other elements (also not shown) carriedon the distal end 114.

Returning to FIG. 1B, in addition to the central lumen 18 a, anauxiliary lumen 18 b may be provided, e.g., extending adjacent thecentral lumen 18 a, e.g., substantially parallel to and radially offsetrelative to the central axis 16. In an exemplary embodiment, theauxiliary lumen 18 b may be a steering element lumen configured toreceive a pull wire or other steering element (not shown, see, e.g., thesteering element 30 shown in FIG. 3) therein, e.g., to bend or otherwisedeflect a distal portion 24 of the apparatus 10, as described furtherbelow. Optionally, the apparatus 10 may include one or more additionallumens (not shown), e.g., one or more additional steering elementlumens, inflation lumens (e.g., if the apparatus 10 includes one or moreballoons, not shown on the distal end 14), and/or accessory lumens.

For example, as shown in FIG. 5A, an apparatus 210 is shown that may begenerally similar to the apparatus 10, e.g., including a central lumen218 a surrounded by an inner liner 240 a and one or more reinforcementmembers 243. Unlike the apparatus 10, the apparatus 210 includes twoauxiliary lumens 218 b, each surrounded by a liner 240 b and having asteering element 230 therein. Similar to the apparatus 10, thereinforcement members 243 include some windings 243 a that pass betweenthe central and auxiliary lumens 218 a, 218 b and some windings 243 bthat surround all of the lumens 218. In a further alternative shown inFIG. 5B, an apparatus 210′ is shown that includes four auxiliary lumens218 b′ with steering elements 230′ therein.

Turning to FIGS. 6A-6G, the auxiliary lumens may have a variety ofcross-sectional shapes. For example, FIG. 6A shows a substantiallycircular auxiliary lumen 18 b with a slightly smaller substantiallycircular steering element 30 disposed therein, e.g., similar to theapparatus 10 shown in FIGS. 1 and 3. In another embodiment, shown inFIG. 6B, the auxiliary lumen 218 b has an elliptical or oval shapeincluding a similarly shaped steering element 230 therein, e.g., similarto the apparatus 210, 210′ shown in FIGS. 5A and 5B. An oval shape mayreduce an outer profile of the apparatus 210, e.g., compared to thecircular lumen 18 b of FIG. 6A, and/or may provide a desired bendingmoment on a distal portion (not shown) of the apparatus 210 whenactuated.

It will be appreciated that other cross-sections may also be provided.For example, FIG. 6C shows a substantially rectangular auxiliary lumen318 b-1 including a similarly shaped steering element 330-1 therein.FIG. 6D shows a curved auxiliary lumen 318 b-1 including a similarlyshaped steering element 330-2, which may define a radius of curvaturecorresponding to the outer circumference or other shape of the catheter,e.g., which may reduce an overall profile of the catheter (not shown).FIG. 6E shows an auxiliary lumen 318 b-3 defined by a pair ofoverlapping circles, which may receive a pair of substantially circularsteering elements 330-3 or a single similarly shaped steering element(not shown).

FIG. 6F shows a pair of substantially circular auxiliary lumens 318 b-4that may be located immediately adjacent one another and may receiverespective substantially circular steering elements 330-4. The steeringelements 330-4 may be actuated independently or simultaneously e.g.,depending on the actuator configuration on the handle of the catheter(not shown).

Finally, FIG. 6G shows a triangular auxiliary lumen 318 b-5 thatincludes a substantially circular steering element 330-5 therein. Such aconfiguration may reduce friction between the steering element 330-5 andthe wall of the auxiliary lumen 318 b-5 since the different shapesminimize contact with one another.

As shown in FIGS. 5A and 5B, the primary lumen 218 a, 218 a′ may have asubstantially circular shape. Alternatively, the primary lumen may haveother shapes and/or cross-sections. For example, as shown in FIG. 7, theprimary lumen 418 a may have a non-circular shape, e.g., a roundedkidney shape, and the auxiliary lumen 418 b may be nested partiallyadjacent the primary lumen 418 a. The non-circular shape may facilitateintroducing instruments through the primary lumen 418 a with reducedfriction, since a rounded or otherwise shaped instrument may havereduced surface contact with the inner surface of the primary lumen 418a. In addition, the non-circular primary lumen 418 a shown in FIG. 7 mayfacilitate introduction of a compressible or otherwise deformableinstrument or device therethrough, since the device may conform at leastpartially to the non-circular shape of the primary lumen 418 a. Thenon-circular primary lumen 418 a may provide a maximum cross-sectionalarea for the primary lumen 418 a while minimizing an overall profile ofthe catheter, e.g., compared to a circular primary lumen, e.g., due tothe additional area provided on either side of the nested auxiliarylumen 418 b.

Returning to FIG. 1A, the distal end 14 may include a tapered, rounded,or otherwise shaped distal tip 15, e.g., to provide a substantiallyatraumatic tip and/or to facilitate advancement or navigation throughvarious anatomy. In addition or alternatively, the distal end 14 mayinclude one or more therapeutic and/or diagnostic elements, e.g., one ormore balloons, stents, sensors, electrodes, ablation elements,thermocouples, steering mechanisms, imaging devices, helical anchors,needles, and the like (not shown), depending upon the particularintended application for the apparatus 10. Further, in addition oralternatively, the distal end 14 may include one or more features toenhance radiopacity and/or visibility under ultrasound, MRI or otherimaging modalities, e.g., by mounting one or more platinum elements onthe distal end 14, doping one or more regions of the distal end 14 withtungsten or barium sulfate, and/or other methods known in the art.

Optionally, as shown in FIG. 1A, the proximal end 12 may include ahandle or hub 21, e.g., configured and/or sized for holding and/ormanipulating the apparatus 10 from the proximal end 12. In addition, thehandle 21 may include one or more ports, e.g., port 22 a communicatingwith the central lumen 18 a, or other respective lumens (not shown).Optionally, the port 22 a may include one or more valves, e.g., ahemostatic valve (also not shown), which may provide a substantiallyfluid-tight seal, while accommodating insertion of one or moreinstruments or fluids into the central lumen 18 a. In addition oralternatively, a side port 22 b may be provided on the handle 21, e.g.,as shown in FIG. 3, e.g., for delivering fluid into and/or aspiratingfluid from the primary lumen 18 a, e.g., around an instrument insertedinto the primary lumen 18 a. Optionally, the handle 21 and/or proximalend 12 may include one or more connectors, such as luer lock connectors,electrical connectors, and the like, for connecting other devices (notshown) to the apparatus 10, such as syringes, displays, controllers, andthe like (also not shown).

In addition, the handle 21 may include one or more actuators, such assliders, buttons, switches, rotational actuators, and the like, e.g.,for activating and/or manipulating components (also not shown) on thedistal end 14 or otherwise operating the apparatus 10. For example, asshown in FIGS. 1A and 3, an actuator 25 may be provided that is coupledto a proximal end 32 of the steering element 30 (shown in FIG. 3) withinthe auxiliary lumen 18 b, as described further below.

Generally, with particular reference to FIG. 1B, the apparatus 10 mayinclude an inner liner 40, e.g., at least partially or entirelysurrounding or otherwise defining the central lumen 18 a, areinforcement layer 42 surrounding the inner liner 40, and an outerjacket 44 surrounding the reinforcement layer 42, each of which mayextend at least partially between the proximal and distal ends 12, 14 ofthe apparatus 10. The reinforcement layer 42 and/or outer jacket 44 maybe attached to the inner liner 40, e.g., by laminating, adhering,adhesive bonding, ultrasonic welding, reflowing or other heating, andthe like, as described elsewhere herein.

In an exemplary embodiment, the central lumen 18 a is defined by aninner liner 40 a including an inner surface 41 a. The inner liner 40 amay be formed from lubricious material, e.g., PTFE, to provide alubricious inner surface 41 a. Alternatively, the inner liner 40 may beformed from one or more layers of thermoplastic or other polymericmaterial including one or more coatings on the inner surface 41 a havingdesired properties, e.g., a hydrophilic and/or lubricious coating, e.g.,similar to the liners disclosed in U.S. Pat. Nos. 7,550,053 and7,553,387, and U.S. Publication No. 2009/0126862, the disclosures ofwhich are expressly incorporated by reference herein.

Optionally, as shown in FIG. 1C, an inner liner 40 b may also at leastpartially surround the auxiliary lumen 18 b, which may be formed from alubricious material and/or may include one or more coatings on its innersurface 41 b, similar to the inner liner 40 a. The inner surface 41 b ofthe auxiliary lumen 18 b may have a substantially uniform cross-section,as shown in FIG. 1C. Alternatively, the inner surface 41 b of theauxiliary lumen 18 b may have a textured or other variable cross-sectionalong, e.g., along its length and/or about its circumference.

For example, as shown in FIG. 1B, the auxiliary lumen 18 b may have anarrower cross-section coextensive with the reinforcement members 43 aand a wider cross-section between the reinforcement members 43 a. Thus,in this embodiment, a steering element (not shown) slidably insertedinto the auxiliary lumen 18 b may contact the narrower regions and passfreely within the wider regions. Such a variable cross-section may beachieved by controlling one or more parameters during manufacturing, asdescribed further elsewhere herein.

Optionally, any or all of the inner liner 40 a, reinforcement layer 42,and/or outer jacket 44 may be formed from multiple layers of like ordifferent materials (not shown), e.g., to provide desired materialproperties in the different portions of the apparatus 10. In anexemplary embodiment, the outer jacket 44 may be formed from PEBAX,nylon, urethane, and/or other thermoplastic material, e.g., such thatthe material of the outer jacket 44 may be heated and reflowed and/orotherwise formed around the components defining the lumens 18, e.g., asdescribed elsewhere herein.

In one embodiment, one or more of the layers of the apparatus 10 mayhave a substantially homogenous construction between the proximal anddistal ends 12, 14. Alternatively, the construction may vary along thelength of the apparatus 10 to provide desired properties, e.g., betweenproximal, intermediate, and distal portions 20, 22, 24. For example, aproximal portion 20 of the apparatus 10 adjacent the proximal end 12 maybe substantially rigid or semi-rigid, e.g., providing sufficient columnstrength to allow the distal end 14 of the apparatus 10 to be pushed orotherwise manipulated from the proximal end 12, while the distal portion24 may be substantially flexible. As described further below, the distalportion 24 of the apparatus 10 may be steerable, i.e., may be bent,curved, or otherwise deflected substantially within a steering plane, asdescribed further below.

Returning to FIG. 1B, the reinforcement layer 42 may include one or morereinforcing members, e.g., wound in a braided or other helicalconfiguration around the inner liner 40 a, and the outer jacket 44 mayinclude one or more tubular layers surrounding the reinforcement layer42 and/or between the reinforcement layer 42 and the inner liner 40 a.In an exemplary embodiment, the reinforcement layer 42 may include oneor more, or a plurality of, round or flat (e.g., rectangular,elliptical, or flat oval) wires, filaments, strands, or otherreinforcement members 43, e.g., formed from metal, such as stainlesssteel, plastic, glass, woven or twisted fibers, such as aramid, and thelike, or composite materials.

In one embodiment, a plurality of reinforcement members 43 may bebraided around the inner liner 40 a, e.g., with each reinforcementmember 43 having the same material and/or shape. Alternatively, thereinforcement members 43 may have different sizes and/or shapes, e.g., afirst size or shape extending helically in a first direction and asecond size or shape (different than the first) extending helically in asecond direction (e.g., opposite the first direction).

The reinforcement layer 42 may be configured to substantially transfertorsional forces between the proximal and distal ends 12, 14, e.g., toallow the apparatus 10 to be twisted from the proximal end 12 to rotatethe distal end 14 about the longitudinal axis 16 within a patient'sbody. In addition, the reinforcement layer 42 may allow the distal end14 of the apparatus 10 to be advanced or otherwise manipulated within apatient's body from the proximal end 12 without substantial risk ofbuckling and/or kinking. The pitch of the reinforcement layer 42 may bevaried along the length of the apparatus 10, e.g., in order to optimizemechanical properties of various segments or portions of the apparatus10.

In the exemplary embodiment shown in FIG. 1B, the reinforcement members43 may be applied around the central lumen 18 a such that a first set ofthe reinforcement members 43 a including windings that pass between thecentral lumen 18 a and the auxiliary lumen 18 b when wrapped around thecentral lumen 18 a, and a second set of reinforcement members includingwindings 43 b that surround both the central lumen 18 a and theauxiliary lumen 18 b. Stated differently, windings of the first set ofreinforcement members 43 a may be wrapped around the inner layer 40surrounding the central lumen 18 a without being wrapped around orsurrounding the auxiliary lumen 18 b, while windings of the second setof reinforcement members 43 b are wrapped around and surround both thecentral lumen 18 a and the auxiliary lumen 18 b, i.e., including regionsdisposed between the auxiliary lumen 18 b and an outer surface of theapparatus 10, as shown in FIG. 1B.

In an exemplary embodiment, the auxiliary lumen 18 b may be radiallyoffset from the central axis 16 substantially along the length of theapparatus 10, e.g., entirely from the distal end 14 to the proximal end12, thereby offset from a center of mass of the apparatus 10 along itslength. In this embodiment, the non-steerable portions of the apparatus10 may be constructed to resist bending, e.g., having a substantiallygreater stiffness than the distal portion 24, such that any bendingmoment generated by a pull wire is applied primarily to the distalportion 24.

Alternatively, the intermediate and/or proximal portions 22, 20 may beconstructed to offset the center of mass from the central axis 16, e.g.,to align the center of mass with the auxiliary lumen 18 b within theintermediate and/or proximal portions 22, 20 (not shown). For example,the apparatus 10 may have a non-circular or other asymmetricalcross-section that minimizes applying a bending moment to theintermediate and/or proximal portions 22, 20, thereby applying anybending moment substantially only to the distal portion 24.

In another embodiment, shown in FIG. 2, an apparatus 110 may be providedthat includes an auxiliary or steering lumen 118 b that extendshelically around an intermediate portion 122 of the apparatus 110 to theproximal portion 120 (or optionally around the proximal portion 120 backto the proximal end 12 of the apparatus 110). As shown, the auxiliarylumen 118 b extends axially along a distal portion 124 while offsetradially from the central axis 116 of the apparatus 110, e.g.,terminating adjacent a distal tip 115 of the apparatus.

A steering element 130 may be slidably received within the auxiliarylumen 118 b with a distal end 134 coupled to the distal tip 115 or otherstructure on the distal end 114. Due to the helical configuration of theauxiliary lumen 118 b in the intermediate portion 122, an axial force onthe steering element 130 (e.g., due to pulling or pushing on thesteering element) may not apply a substantial bending moment on theintermediate portion 122. However, because the auxiliary lumen 118 b isoffset radially from the central axis 116 of the apparatus 110 along thedistal portion 124, an axial force applied to the steering element 130applies a bending moment to the distal portion 124, thereby causing thedistal portion 124 to curve or otherwise bend. More generally, the pathof the auxiliary lumen 118 b may be varied along the length of theapparatus 110, e.g., to control where a bending moment is applied and/orgenerate a complex curve in one or more segments of the apparatus 110.

In an alternative embodiment, the auxiliary or steering element lumenmay be aligned with the central axis of the apparatus within theintermediate portion (not shown) and offset radially from the centralaxis within the distal portion. For example, the distal portion may beformed from a tubular body constructed similar to that shown in FIG. 1B,while the intermediate and/or proximal portions may be formed with theauxiliary lumen aligned with the central axis and/or center of mass ofthe apparatus (not shown).

With additional reference to FIGS. 1A and 3, if the distal portion 24 ofthe apparatus 10 is steerable, one or more pull wires, cables, fibers,threads, filaments, or other steering elements, such as pull wire 30shown in FIG. 3 may be slidably received within the auxiliary lumen 18b. The pull wire 30 generally includes a proximal end 32 coupled to theactuator 25 on the handle 21 and extends through the intermediateportion 22 and into the distal portion 24. A distal end 34 of thesteering element 30 may be fixed or otherwise coupled to the distal end14, e.g., to a component defining or adjacent the distal tip 15, asshown in FIG. 3. The steering element 30 may be formed from materialscapable of substantially transferring any axial forces applied at theproximal end 32 to the distal end 34, as is known in the art.Optionally, the steering element 30 may include a coating, e.g., PTFE,parylene, silicone, or other lubricious material, an outer sleeve, e.g.,formed from HDPE, PTFE, and the like, to reduce friction between thesteering element 30 and the wall of the auxiliary lumen 18 b.Alternatively or in addition, the inner surface 41 b of the auxiliarylumen 18 b may be formed from lubricious material and/or may include oneor more coatings, as described elsewhere herein. Alternatively or inaddition, the auxiliary lumen 18 b may include one or moreincompressible elements, e.g., a tightly wound coil therearound, e.g.,to prevent compression, which may otherwise lead to creating a bendingmoment along at least part of its length.

During use, the actuator 25 may be activated, e.g., directed proximallyor distally relative to the handle 21 and/or the proximal end 12, toapply an axial force to the steering element 30, e.g., tension (when thesteering element 30 is pulled) or compression (when the steering element30 is advanced). Because the steering element 30 is slidable within theauxiliary lumen 18 b, the axial force is translated and applied to thedistal end 34 coupled to the distal end 14. Because the auxiliary lumen18 b is offset from the central axis 16 along at least the distalportion 24, the axial force applies a bending moment, thereby causingthe distal portion to curve or otherwise bend in a desired plane orother manner, e.g., as shown in phantom in FIG. 3. As explainedelsewhere herein, the proximal and intermediate portions 20, 22 of theapparatus 10 may be constructed to prevent or minimize bending forcescaused by actuation of the steering element 30.

With additional reference to FIG. 1B, the bending moment caused by thesteering element 30 within the auxiliary lumen 18 b of the distalportion 24 applies radial forces against the wall of the auxiliary lumen18 b. For example, when a proximal force is applied, e.g., to cause thedistal portion 24 to bend as shown in phantom in FIG. 3, the steeringelement 30 may apply an outward force against the inner surface 41 b ofthe auxiliary lumen 18 b, i.e., away from the central lumen 18 a.Because at least some of the windings 43 b (e.g., half) of thereinforcement layer 42 surround the auxiliary lumen 18 b, the windings43 b may support the wall of the auxiliary lumen 18 b and the adjacentouter jacket 44, thereby reducing the risk of tearing or otherwisedamaging the material outside the auxiliary lumen 18 b. Conversely, whena distal force is applied, e.g., to cause the distal portion to bendopposite to that shown in phantom in FIG. 3, the steering element 30 mayapply an inward force against the inner surface 41 b of the auxiliarylumen 41 b, i.e., towards the central lumen 18 a. Again because at leastsome of the windings 43 a (e.g., half) surround the central lumen 18 a,passing between the central and auxiliary lumens 18 a, 18 b, thewindings 43 a may support the wall of the auxiliary lumen 18 b and theinner liner 40 a surrounding the central lumen 18 a, thereby reducingthe risk of tearing or otherwise damaging the material outside theauxiliary lumen 18 b, e.g., tearing into the central lumen 18 a.Additionally, when a rotational force is applied to the apparatus 10while its distal portion 24 is being caused to bend, the steeringelement 30 may apply at least some component of lateral force within thewall of the apparatus 10, which alone or in combination with the inwardand/or outward force described above, may tend to separate the adjacentlayers of the apparatus 10, but for the surrounding windings 43 a and 43b that reinforce the auxiliary lumen 18 b on all sides.

By comparison, catheters that wrap reinforcement members only aroundboth lumens may risk tearing and/or separation, e.g., when a distalforce is applied to the steering element. Likewise, catheters that wrapreinforcement members only around a central lumen and then add an outersteering lumen may risk tearing and/or separation, e.g., when a proximalforce is applied to the steering element, and/or may increase theprofile of the resulting catheter.

With continued reference to FIG. 1B, wrapping some windings 43 b of thereinforcement members 43 b around both lumens 18 a, 18 b and somewindings 43 a just around the central lumen 18 a may reduce an overallcross-section of the apparatus 10. For example, additional reinforcementmembers that may otherwise be added to support a steering element lumenmay be eliminated since the windings 43 a, 43 b automatically supportthe apparatus 10 on all sides of the auxiliary lumen 18 b.

In addition, this configuration of reinforcement members may alsoenhance torque transmission properties of the apparatus 10. For example,in the embodiment shown in FIG. 2, the auxiliary lumen 118 b may bewound helically around the central lumen 118 a. When the proximal end(not shown) of the apparatus 110 is rotated to torque the distal portion124, the helical region of the auxiliary lumen 118 b may enhancetranslation of the torque to the distal portion 124. In general, it maybe sufficient to have one to three rotations of the auxiliary lumen 118b in the intermediate region per one hundred eight degrees (180°) oftortuosity.

Turning to FIGS. 4A-4C, various methods may be used for manufacturingand/or assembling any of the embodiments described herein. For example,FIG. 4A shows an exemplary embodiment of an apparatus 50 for making oneor more tubular bodies, such as catheters and/or components forcatheters, sheaths, or other tubular devices 8. Generally, the apparatus50 includes a plurality of sources 52, 54 of mandrels 2 and/or liners 4,a guide 60, a source 70 of reinforcement members 6, a drive mechanism80, and, optionally, a source 90 of jacket material 7.

The apparatus 50 may allow for substantially continuous fabrication oftubular bodies, e.g., wrapping a liner material 4 a around a primarymandrel 2 a (or the primary mandrel 2 a may include a tubular or otherliner material provided around it on the source 52, e.g., similar to theliners disclosed in the references incorporated by reference elsewhereherein), positioning an auxiliary mandrel 2 b (with optional linermaterial) adjacent the primary mandrel 2 a, braiding a plurality ofreinforcement members 4 around the mandrels 2, and optionally, applyingouter jacket material 7 around the reinforced mandrels, as describedfurther below.

As used herein, “substantially continuous” means that the apparatus 50and/or method may operate indefinitely, i.e., to make as few as one oras many as hundreds or thousands of tubular bodies 8, e.g., bysubstantially simultaneously feeding components of the tubular bodies 8from sources 52, such as reels, through components of the apparatus 50until the sources 52 are depleted, whereupon new source(s) may be loadedonto the apparatus 50 and the process continued. Alternatively, theapparatus 50 may be used to create discrete lengths of tubular devices,e.g., if the mandrels and/or liners are provided in specific lengthscorresponding to one or more individual tubular devices (not shown). Ina further alternative, some of the operations may be performedsubstantially continuously, while other operations are performed oncomponents intended for one or more individual tubular devices.

Thus, the apparatus 50 and methods herein may be used to make one ormore relatively long tubular bodies 8, e.g., that are substantiallylonger than finished catheters or other tubular devices. For example,one resulting tubular body 8 may be collected, e.g., on a take-up reelor container (not shown), or may be separated into individual shortertubular bodies, e.g., using a cutter or other tool (not shown), that maybe incorporated into individual catheters or other tubular devices,e.g., as described elsewhere herein and/or as disclosed in U.S.Publication No. 2009/0126862, the entire disclosure of which isexpressly incorporated by reference herein.

With particular reference to FIG. 4A, the apparatus 50 may include oneor more sources 52 of mandrels 2 and, optionally, one or more sources 54of liner material 4, which may be fed into a guide 60 to define lumensof the tubular bodies 8. For example, a first reel 52 a may include anelongate primary mandrel 2 a, e.g., shaped and/or configured to define aprimary or central lumen (not shown) of the tubular bodies 8. Similarly,a second reel 52 b may include an elongate auxiliary mandrel 2 b, e.g.,shaped and/or configured to define a secondary or auxiliary lumen (alsonot shown) of the tubular bodies 8. Optionally, if additional lumens aredesired for the tubular bodies 8, one or more additional auxiliarymandrels may be provided (not shown).

The mandrels 2 may have desired cross-sectional shapes and/or sizescorresponding to the desired cross-sections of the lumens, e.g.,substantially circular or other shapes, as described elsewhere herein.The mandrels 2 may be a solid or hollow wire or other cylindrical memberhaving a diameter (or other cross-section) corresponding to the diameterof the lumen to be lined by the strip, e.g., between about 0.005-0.300inch (0.125-7.5 mm), 0.014-0.092 inch (0.35-2.3 mm), or 0.014-0.045 inch(0.35-1.15 mm). In an exemplary embodiment, the auxiliary mandrel 2 bmay have a substantially smaller diameter or other cross-section thanthe primary mandrel 2 a. In exemplary embodiments, the mandrels 2 may beformed from beading or monofilament material, for example, lubriciousmaterial, e.g., PTFE or other fluoropolymer, silicone-treated Acetal,PTFE-coated stainless steel, Parylene-coated stainless steel, and thelike, having sufficient flexibility to allow the mandrels 2 to be woundonto a source reel 52 and/or onto a take-up reel (not shown) after beingincorporated into a tubular body 8.

Alternatively or in addition, the mandrels 2 may have a tubular linerpredisposed about them, e.g. a fluoropolymer sleeve or coating or othertubular material which may facilitate removal of the mandrel 2 and/or beleft behind upon removal of the mandrel 2 to form a liner. Furtheralternatively, a shim (not shown) may be positioned over a mandrel 2and/or within a tubular or strip liner such that the shim (not shown)may facilitate creation of a lumen that is larger than the mandrel 2with or without ultimate removal of the mandrel 2. For example, a PTFEtube or strip shim (not shown) may be positioned around a mandrel 2 andinside of a strip or tubular liner. The mandrel/shim/liner assembly maythen be incorporated into a braided shaft or finished apparatus. Theshim (not shown) may be subsequently removed, e.g. after braiding,lamination, etc. to leave a lumen larger than the mandrel. After this,the mandrel may remain in place, for example in the case of theauxiliary mandrel 2 b to serve as a pull wire, or simply removed withless force.

In an alternative embodiment, the mandrels 2 may be formed from materialthat substantially maintains its size and shape during fabrication ofthe tubular bodies, yet may be reduced in cross-section afterfabrication to facilitate removal. For example, silver-coated copperwire or other malleable metals may be used for the mandrels 2 that,after fabrication of the tubular body 8, may be necked down before beingremoved. For example, after fabricating a tubular body 8, the mandrels 2(or the entire tubular body) may be pulled at each end, thereby causingthe mandrels 2 to plastically elongate and thereby reduce their outercross-section slightly, which may reduce friction between the mandrels 2and the surrounding liners, reinforcement members, and/or othermaterials, and thereby facilitate removal. Further alternatively, themandrels 2 may include a rolled strip with inherent radial strengthcapable of supporting a lumen during braiding and/or lamination and/orother processing, but may subsequently be constrained, stretched, orotherwise removed. Further alternatively, the mandrels 2 may beconstructed from material having relatively high thermal expansion suchthat during heating, lamination, and/or reflow, the mandrels 2 expandand upon cooling contract, thereby creating a lumen larger than theoriginal mandrel 2.

In yet another alternative, the mandrels 2 may be formed from materialsthat may be dissolved, e.g., after fabrication, leaving the surroundingmaterials intact to define the lumens.

In still another alternative, tubular mandrels may be used that havesufficient hoop strength to resist deformation under the forcesencountered during braiding and/or other fabrication and/or heating orother processing parameters experienced during fabrication. In thisalternative, the tubular mandrels may remain substantially within thetubular bodies 8 after fabrication, e.g., to define the auxiliary lumen.For example, a relatively thick walled PTFE, a lined or bare polymidetube, or other tubular mandrel may be used. Alternatively, the innerdiameter of such a tubular mandrel may be temporarily supported by atemporary supporting mandrel (not shown), e.g. during braiding, and thetemporary supporting mandrel may be removed prior to subsequentfabrication and/or heating or other processing steps, e.g., if thetubular mandrel is to remain as a permanent component of the tubularbodies.

Optionally, a source 54 of liner material 4 may be provided for the oneor both mandrels 2. For example, as shown, a source 54 a of linermaterial 4 a is provided such that the liner material 4 a may be wrappedat least partially around the primary mandrel 2 a, e.g., as the primarymandrel 2 a and liner material 4 a are fed through the guide 60. Theliner material 4 a may be formed from lubricious material and/or mayinclude one or more coatings (not shown) on an inner surface thereoforiented towards the primary mandrel 2 a, which may provide an innerliner for a primary lumen of the resulting tubular bodies 8 a.

For example, the liner material may include a base material, e.g., arelatively thin-walled polymer sheet having a width corresponding to thecircumference of the corresponding mandrel, e.g., thermoplastics, suchas polyether block amide, urethane, nylon, and the like, fluoropolymers,such as PTFE, FEP, TFE, and the like, thermoset, and thermoformplastics, such as polyimide or polyester, and the like. In exemplaryembodiments, the liner material may have a thickness between about0.0001-0.050 inch (0.0025-1.25 mm), 0.0001-0.003 inch (0.0025-0.076 mm),0.0001-0.0015 inch (0.0025-0.038 mm), or 0.0005-0.002 inch (0.0125-0.05mm).

Optionally, if desired a source of liner material may also be providedfor the auxiliary mandrel 2 b and/or for other auxiliary mandrels (notshown for simplicity). In this option, a guide (not shown) may beprovided for wrapping the liner material around the auxiliary mandrel 2b, e.g., before the auxiliary mandrel 2 b is positioned adjacent theprimary mandrel 2 a. In an alternative embodiment, tubular linermaterial may be provided on one or both mandrels when loaded on thesource 52, and/or may be fed onto the desired mandrel in discretesegments (not shown) before passing the mandrels 2 through the guide 60or horn gear 72.

With additional reference to FIGS. 4A and 4B, the source 70 ofreinforcement members 6 may provide one or more, e.g., a plurality of,reinforcement members 6 that may be wrapped around the mandrels 2, e.g.,upon exiting the guide 60. In the exemplary embodiment shown in FIG. 4B,the reinforcement source 70 may include an arrangement of horn gears 72,e.g., mounted in a generally circular configuration around the guide 60,for example, to a base or other support structure 76. The horn gears 72may be free to rotate about their individual central axes but may besubstantially fixed translationally relative to one another and theguide 60. Alternatively, the horn gears 72 may be rotatable relative tothe guide 60, e.g., around a central axis of the guide 60, whilemaintaining their same circular configuration, e.g., by rotating thebase 76 relative to the guide 60, as described further elsewhere herein.

In addition, one of the horn gears 72 a may include a passage 73 atherethrough, e.g., aligned with the central axis of the horn gear 72 a,and the auxiliary mandrel 2 b may pass through the passage 73 a, e.g.,from the source 52 b towards the primary mandrel 2 a where it exits theguide 60. If liner material is wrapped or otherwise disposed around theauxiliary mandrel 2 b, a guide (not shown) may be provided before,after, or within the passage 73 a to wrap or otherwise dispose the linermaterial around the auxiliary mandrel 2 b. Optionally, if additionalauxiliary lumens are to be provided in the tubular bodies 8, one or moreadditional horn gears may also include such passage(s) and/or guide(s)for guiding corresponding auxiliary mandrel(s) therethrough. It will beappreciated that the number of auxiliary lumens available for thetubular bodies may be limited by the number of horn gears 72 in thereinforcement source 70 (unless multiple mandrels and/or liners aredirected through a single passage, e.g., to form a lumen, such as thatshown in FIG. 6F. For example, in the embodiment shown in FIG. 4B, sixhorn gears 72 are provided and so six auxiliary mandrels may be providedthat pass through respective horn gears 72. The number of horn gears maybe increased or decreased, as desired, to provide a desired number ofreinforcement members and/or auxiliary lumens, e.g., four, eight,twelve, sixteen, or other numbers of horn gears (not shown), or othergenerally symmetrical configuration.

Optionally, if desired, individual carriers may be loaded with multiplereinforcement members (not shown), e.g., such that multiplereinforcement members are braided adjacent one another in each directionfrom each carrier.

In the exemplary embodiment shown in FIG. 8, a first set ofreinforcement members 43 a may travel and be braided in a firstdirection by the horn gears 72 such that all of the windings of thefirst set 43 a pass between the auxiliary mandrel 2 b and the primarymandrel 2 a at that specific horn gear. A second set of reinforcementmembers 43 b may travel and be braided in a second opposite direction bythe horn gears 72 such that all of the windings of the second set 43 bpass over the auxiliary mandrel 2 b at that specific horn gear.Otherwise, the reinforcement members may pass over and under one anotheraccording to the arrangement of horn gears 72 and carriers 74 loadedonto the reinforcement source 70, which pattern generally alternates ateach subsequent horn gear.

In addition, one of the horn gears 72 a may include a passage 73 atherethrough, e.g., aligned with the central axis of the horn gear 72 a,and the auxiliary mandrel 2 b may pass through the passage 73 a, e.g.,from the source 52 b towards the primary mandrel 2 a where it exits theguide 60. If liner material is wrapped or otherwise disposed around theauxiliary mandrel 2 b, a guide (not shown) may be provided before,after, or within the passage 73 a to wrap or otherwise dispose the linermaterial around the auxiliary mandrel 2 b. Optionally, if additionalauxiliary lumens are to be provided in the tubular bodies 8, one or moreadditional horn gears may also include such passage(s) and/or guide(s)for guiding corresponding auxiliary mandrel(s) therethrough. It will beappreciated that the number of auxiliary lumens available for thetubular bodies may be limited by the number of horn gears 72 in thereinforcement source 70 (unless multiple mandrels and/or liners aredirected through a single passage, e.g., to form a lumen, such as thatshown in FIG. 6F. For example, in the embodiment shown in FIG. 4B, sixhorn gears 72 are provided and so six auxiliary mandrels may be providedthat pass through respective horn gears 72. The number of horn gears maybe increased or decreased, as desired, to provide a desired number ofreinforcement members and/or auxiliary lumens, e.g., four, eight,twelve, sixteen, or other numbers of horn gears (not shown), or othergenerally symmetrical configuration.

With further reference to FIG. 4C, as can be seen, the primary mandrel 2a may exit the guide 60 with the liner material 4 a being wrappedsubstantially around the primary mandrel 2 a. The auxiliary mandrel 2 bmay be directed towards the primary mandrel 2 a such that the auxiliarymandrel 2 b is disposed immediately adjacent the primary mandrel 2 a,e.g., at the location where the reinforcement members 6 converge on theprimary mandrel 2 a. During operation, the reinforcement members 6 maybe braided around the primary mandrel 2 a such that some of the windings43 pass over the auxiliary mandrel 2 b and others pass under theauxiliary mandrel 2 b, e.g., as shown in FIG. 4C. More particularly,given the configuration of horn gears in FIGS. 4A and 4B, half of thereinforcement members 6 are wrapped in a first, e.g., clockwise,direction, with alternate windings passing over and under the auxiliarymandrel 2 b, and half of the reinforcement members 6 are wrapped in asecond, e.g., counterclockwise, direction with alternate windingspassage over and under the auxiliary mandrel 2 b. Thus, in this manner,all of the reinforcement members 6 may surround the primary mandrel 2 a,while only some windings 43 a may surround the auxiliary mandrel 2 b, asshown in FIG. 4D. In an exemplary configuration, all of the carriers 74passing in the first direction may cause their reinforcement members topass over the reinforcement members of the carriers 74 passing in thesecond direction.

The drive mechanism 80 may include one or more components for pulling orotherwise directing the mandrels 2 through the apparatus 50. Forexample, the drive mechanism 80 may include a pair of spaced-apartrollers 82 coupled to a motor (not shown) that engage thereinforcement-wrapped mandrels 2 and apply sufficient tension to pullthe mandrels 2 from their sources 52 through the guide 60 and/or horngear 72 a while the reinforcement members 6 are braided around themandrels 2. Alternatively, the drive mechanism may be provided beforethe reinforcement members 6 are braided around the mandrels 2, e.g.,pushing the primary mandrel 2 a through the braiding operation andpotentially pulling the auxiliary mandrel 2 b by the braiding actionitself. Optionally, other drive mechanisms and/or tension adjusters (notshown) may be provided for maintaining a desired tension and/orotherwise guiding the mandrels 2, liners 4, reinforcement members 6, andassembled device in a desired manner along the fabrication path.

Optionally, as shown in FIG. 4A, the jacket source 90 may be providedfor applying one or more layers of jacket material around thereinforcement-wrapped mandrels 2. For example, a co-extruder, laminator,or other applicator may be provided that applies melted, uncured, and/orotherwise raw jacket material 7, e.g., from a hopper or other container(not shown), or rolls sheets of jacket material 7 may be wrapped aroundthe reinforcement members 43 and mandrels 2.

For example, for thermoplastic or other flowable materials, a heater(not shown) within a co-extruder may melt or otherwise soften the jacketmaterial 7 to allow the jacket material 7 to flow around thereinforcement members 43 and into contact with the liner material 4surrounding the mandrels 2 (or the mandrels 2 directly if no linermaterial is provided). Alternatively, the jacket material 7 may be athermoset plastic or other material such that components of the jacketmaterial 7 may be delivered into the co-extruder, e.g., as a liquid,powder, and the like, and mixed to form a slurry that is deliveredaround the reinforcement-wrapped mandrels 2. The components maychemically or otherwise react with one another and/or be heat fused toform a solid jacket 7 once cured. Exemplary materials for the jacketmaterial 7 include plastics, e.g., thermoplastics, such as polyetherblock amide, nylon, or urethanes, thermoset plastics, metals, orcomposite materials. Alternatively, other processing may be used to bondor otherwise attach the jacket material 7 to the liner material 4 and/orembed the reinforcement members 43 in the jacket material 7, therebyresulting in an integral tubular body 8.

The resulting tubular body 8 (with or without jacket material 7) may becollected, e.g., on a capture reel or in a container (not shown).Thereafter, the tubular body 8 may be further processed to make acatheter, sheath, or other device. For example, a cutter or other tool(not shown) may separate the tubular body 8 into individual tubularshafts, e.g., before or after removing the mandrels 2. For example, themandrels 2 may remain within the tubular body 8 when cut into individualdevices, and then may be removed, resulting in a primary lumen and anauxiliary lumen, e.g., similar to the apparatus 10 shown in FIG. 1B.Alternatively, if the friction between the mandrels 2 and thesurrounding material is relatively low, the mandrels 2 may be removedbefore the tubular body 8 is cut into individual devices.

The resulting inner surface 41 a of the primary lumen 18 a may have asubstantially uniform cross-section, e.g., as shown in FIG. 1B. Similarthe auxiliary lumen 18 b may also have a substantially uniformcross-section, e.g., as shown in FIG. 1C. Alternatively, the innersurface 41 b of the auxiliary lumen 18 b may have a variablecross-section. Such a variable cross-section may be achieved bycontrolling one or more parameters during fabrication. For example, suchvariables may include a) the tension applied when the reinforcementmembers 6 are wrapped around the auxiliary mandrel 2 b, b) the softnessand/or elasticity of the auxiliary mandrel 2 b, c) the tension appliedto the auxiliary mandrel 2 b as it is directed into contact with theprimary mandrel 2 a, and/or d) the material of liner material around theauxiliary mandrel 2 b.

In an exemplary embodiment, the reinforcement materials 43 a may beformed from material having a lower coefficient of friction than thesurrounding jacketing material (e.g., if no liner material is applied),which may decrease the frictional resistance of the steering element(not shown) within the auxiliary lumen 18 b when it slides along thereinforcement members 43 a. In addition or alternatively, as shown inFIG. 1B, the increased cross-section between the reinforcement members43 a may minimize or entirely avoid contact between the steering elementand the material surrounding the auxiliary lumen 18 b between thereinforcement members 43 a.

Other components may be added to the individual tubular devices, asdesired for the particular application. For example, for a steerablecatheter, a steering element may be inserted through the auxiliary lumencreated when the auxiliary mandrel 2 b is removed. In an alternativeembodiment, the auxiliary mandrel 2 b may remain within the tubulardevice to provide the steering element, e.g., if the friction betweenthe outer surface of the auxiliary mandrel 2 b and the liner or othermaterial defining the auxiliary lumen are relatively low. A tip or othercomponent may be attached to a distal end of the tubular device, e.g.,after attaching one end of the steering element to the tip. The otherend of the steering element may be coupled to an actuator of a handleattached to a proximal end of the tubular device, e.g., similar toembodiments described elsewhere herein.

In another method, the apparatus 50 may be used to create an auxiliarylumen (or multiple auxiliary lumens, if desired) that extend helicallyaround at least a portion of the primary lumen. For example, asdescribed above, the base 76 and horn gears 72 of the reinforcementsource 70 may remain substantially fixed relative to the guide 60 anddrive mechanism 80, which results in the auxiliary mandrel 2 b extendingsubstantially parallel and adjacent to the primary mandrel 2 a.Consequently, this method results in an auxiliary lumen that alsoextends substantially parallel and adjacent to a primary or centrallumen, e.g., as shown in FIG. 1B.

Alternatively, the base 76 may be rotatable relative to the guide 60 anddrive mechanism 80, e.g., coupled to a motor or other driver that mayselectively or continuously rotate the base 76, thereby rotating thehorn gears 72 around the guide 60. Consequently, in this alternative,the horn gear 72 a including the passage 73 a for the auxiliary mandrel2 b may rotate relative to the primary mandrel 2 a, thereby directingthe auxiliary mandrel 2 b spirally around the primary mandrel 2 a as thereinforcement members 6 are braided around them.

This rotation may be driven at a desired, e.g., fixed or variable, speedto result in a desired, e.g., fixed or variable, distance betweenadjacent windings of the auxiliary mandrel 2 b around the primarymandrel 2 a. The rotation may be maintained substantially continuously,e.g., if it is desired for the auxiliary mandrel 2 b to spiral along theentire length of the primary mandrel 2 a, or for desired limited timeperiods, e.g., resulting in sections of the tubular body 8 where theauxiliary mandrel 2 b spirals around the primary mandrel 2 a for desiredlengths separated by sections where the auxiliary mandrel 2 b extendssubstantially parallel to the primary mandrel 2 a.

In an alternative embodiment, the base 76 and horn gears 72 may befixed, and instead the drive mechanism 70 may be rotated, e.g., torotate the reinforcement-wrapped mandrels 2 relative to the earliercomponents of the apparatus 50. For example, the rollers 72 may berotated about the central axis while engaging the reinforcement-wrappedmandrels 2 to cause the entire assembly to rotate, causing the auxiliarymandrel 2 b to spiral relative to the primary mandrel 2 a before or asthe reinforcement members 6 are braided on.

In an exemplary embodiment, the apparatus 50 may be alternated betweenfixed and rotating operations, thereby alternatively spiraling theauxiliary mandrel 2 b around the primary mandrel 2 a and directing theauxiliary mandrel 2 b substantially parallel to the primary mandrel 2 a.The resulting tubular body 8 may be separated into multiple deviceshaving spiral and straight sections of the auxiliary mandrel 2 b, whichmay then be incorporated into individual catheters or other devices.Consequently, this method may result in an auxiliary lumen that spiralsaround a primary or central lumen along a portion of a tubular device(e.g., an intermediate and/or proximal portion), and extendssubstantially parallel and adjacent to the central lumen along anotherportion (e.g., a distal portion), e.g., similar to the apparatus 110shown in FIG. 2.

One of the advantages of the methods for making tubular bodies describedherein is that the reinforcement members, in addition to providingdesired reinforcement in the final devices, may also substantiallysecure the mandrels 2 and/or other components of the tubular bodiesduring fabrication. For example, one potential problem with usingmultiple tubular members to fabricate a single device with multiplelumens is undesired movement between the components. With the methodsdescribed herein, the reinforcement members may substantially secure themandrels 2 (and any liners surrounding them) relative to one anotherimmediately upon braiding. For example, the reinforcement members mayfrictionally engage the mandrels or liners, or even partially embed intothe liners, which may minimize the risk of these components subsequentlymoving relative to one another, particularly if jacketing is appliedafter collecting and/or storing the reinforcement-wrapped mandrels for aperiod of time.

In addition, the apparatus and methods herein may facilitatetransitioning the auxiliary lumen at one or both ends of a tubulardevice. For example, as shown in FIG. 3, the apparatus 10 includes atransition within the handle 21 of the auxiliary lumen 18 b out of thewall of the tubular member, e.g., to allow the steering element 30 toextend from the proximal end 12 such that the proximal end 32 may becoupled to the actuator 25.

To accomplish this, a portion of the auxiliary mandrel 2 b may bedisengaged from the braider such that the portion remains entirelyoutside the reinforcement members. FIG. 8 shows a detail of such aconfiguration. For example, after a desired portion of the auxiliarymandrel 2 b has been braided to the primary mandrel 2 a by thereinforcement members 6, the auxiliary mandrel 2 b may be cut orotherwise separated from the horn gear 72 and positioned outside thebraiding point. Thus, as reinforcement members 6 continue to be braidedaround the primary mandrel 2 a, the auxiliary mandrel 2 b remainsoutside the braid, as shown in FIG. 8.

Subsequently, when jacket material 7 is applied around thereinforcement-wrapped mandrels 2, the auxiliary mandrel 2 b may extendout of the jacket material 7 at one end. When the auxiliary mandrel 2 bis removed, a side port may be provided on the end of the jacketedtubular body that communicates with the resulting auxiliary lumen 18 b.This end may be positioned inside the handle 21, e.g., as shown in FIG.3, before or after inserting a steering element 30 through the auxiliarylumen 18 b. With the proximal end 32 of the steering element 30extending from the side port, the proximal end 32 may be coupled to theactuator 25, e.g., using conventional methods.

This method may provide a substantially uniform and consistent way toinsert and couple steering element to a tubular device. In otherextrusions or multiple lumen catheters (not shown), the side wall of theproximal may have to be slit or otherwise penetrated to access asteering element lumen therein and insert a steering element. Suchskiving, slitting, or penetration may create a weak point in the wall ofthe tubular device and/or may risk puncturing into the primary lumen,e.g., such that air or other contaminants may communicate between thelumens of the tubular device. Such risks may be avoided by positioningthe auxiliary mandrel 2 b outside the reinforcement members at a regioncorresponding to the proximal end of the desired tubular device.

Turning to FIG. 9, another exemplary embodiment of a catheter or otherapparatus 510 is shown that includes an elongate tubular memberincluding a proximal end (not shown), a distal end 514, and a steerabledistal portion 524 sized for insertion into a body lumen, a centrallongitudinal axis 516 extending between the proximal and distal ends514, and one or more lumens 518 extending between the proximal anddistal ends 514, constructed generally similar to other embodimentsherein. For example, the catheter 510 may include a central or primarylumen extending from the proximal end to an outlet (not shown) in thedistal end 514, e.g., to allow a guidewire, catheter, or otherinstrument (not shown) to pass therethrough and/or for delivering oraspirating fluid therethrough.

In addition, the catheter 510 may include one or more auxiliary lumens,e.g., extending adjacent the central lumen at least partially betweenthe proximal and distal ends 514, e.g., substantially parallel to andradially offset relative to the central axis 516 at least along thedistal portion 524. In an exemplary embodiment, the auxiliary lumen(s)may be a steering element lumen configured to slidably receive a pullwire or receive another steering element 530 therein, e.g., to bend orotherwise deflect the distal portion 524 of the apparatus 510, similarto other embodiments herein. Optionally, the catheter 510 may includeone or more additional lumens (not shown), e.g., one or more additionalsteering element lumens, inflation lumens, and/or accessory lumens.

Generally, the apparatus 510 includes an inner liner 540, e.g., at leastpartially or entirely surrounding or otherwise defining the centrallumen (shown in FIG. 10), a reinforcement layer 542 surrounding theinner liner 540 (also shown in FIG. 10), and an outer jacket 544surrounding the reinforcement layer (shown in FIG. 9), each of which mayextend at least partially between the proximal and distal ends 514 ofthe apparatus 510, as described elsewhere herein.

The distal portion 524 may include a tapered, rounded, or otherwiseshaped distal tip 515, e.g., to provide a substantially atraumatic tipand/or to facilitate advancement or navigation through various anatomy.Optionally, the distal end 514 may include one or more features toenhance radiopacity and/or visibility under ultrasound, MRI or otherimaging modalities (not shown), similar to other embodiments herein.

Optionally, similar to the apparatus 10 shown in FIG. 1A, the proximalend may include a handle or hub, which may include one or more ports,e.g., a port communicating with the central lumen, one or moreactuators, e.g., for actuating the pull wire 530, and/or one or moreconnectors, e.g., for coupling a sensor and/or controller to theapparatus 10, also similar to other embodiments herein.

As shown in FIGS. 9 and 11A-11D, the catheter 510 includes a pluralityof electrodes and/or sensing elements 550 on the distal portion 514 anda plurality of wires 552 extending proximally from the electrodes 550,e.g., to the proximal end and/or one or more connectors on or extendingfrom the handle (not shown). As shown in FIG. 9, the electrodes 550 maybe spaced apart from one another at predetermined intervals along thedistal portion 524. Alternatively, or in addition to, one or moreelectrodes may be positioned more proximally on the catheter 510 (notshown). In the embodiment shown, the electrodes 550 are spot electrodesapplied on one side of the distal portion 524 such that the electrodes550 are aligned substantially axially relative to one another.Alternatively, one or more of the electrodes may be offsetcircumferentially from others (not shown), if desired. In a furtheralternative, the electrodes may comprise other non-circumferential orcircumferential and/or other symmetric or asymmetric geometries, e.g.,the electrodes may be a button, a patch, a square, a rectangle, apartial ring, a ring, a coil, or other type of electrodes that extendpartially or completely around the circumference of the distal portion524.

The electrodes 550 may be at least partially set into the wall of thedistal portion 524, e.g., to provide a secure attachment and/orsubstantially smooth and/or atraumatic outer surface for the distalportion 524. For example, at least a portion of the outer layer 544 ofthe distal portion 514 may be removed, e.g., to provide a recess for theelectrodes 550 and/or to expose the wires 552 or otherwise allow thewires 552 to be coupled to the electrodes 550, as described furtherelsewhere herein.

The wires 552 may be embedded within the wall of the distal portion 524,e.g., braided/positioned/embedded within elements of the reinforcementlayer 542 adjacent a primary lumen and/or auxiliary lumen. In theembodiment shown in FIG. 10, a pair of wires 552′ are shown immediatelyadjacent one another and adjacent a mandrel/liner 502 for forming anauxiliary lumen and oriented such that the wires 552 extendsubstantially parallel to the longitudinal axis 516 of the apparatus510. One disadvantage of orienting the wires 552 substantially axiallyalong the distal portion 524 is that the wires may be subjected totension and/or compression during use of the apparatus 510, which mayrisk damaging the wires 552 during use of the apparatus 510.

For example, when the distal portion 524 is deflected into a curvedconfiguration, if the wires 552 are on the outside of the bend, thewires 552 may be subjected to axial tension, and conversely, if thewires 552 are on the inside of the bend, the wires 552 may be subjectedto axial compression, risking buckling or kinking. In particular, wires552 may be formed from relatively inelastic and/or ductile material,e.g., copper, and the like, which may not accommodate repeated bendingand risk of cracking or breaking, which may create a hot spot, short,and/or interference/artifact in sensed signals.

In addition, orienting the wires 552 substantially axially may modifythe intended bending forces applied by the steering element 530 of theapparatus 510 in an undesirable manner. However, the wires 552 may bepositioned at a desired circumferential location, e.g., to minimizeinteraction of the wires 552 with the deflection of the distal portion524 during use. For example, the wires 552 may be positionedsubstantially along a side of the distal portion 524 corresponding to aneutral axis of the distal portion 524, e.g., offset about ninetydegrees (90°) from the deflection plane of the distal portion 524.

In an alternative embodiment, the wires 552 may be oriented within thedistal portion 524 in a configuration to accommodate bending ordeflection of the distal portion 524. For example, as shown in FIGS.11A-11D, three wires 552 are shown that extend along the distal portion524 in a generally sinusoidal pattern immediately adjacent one another,optionally substantially centered on the neutral axis of the distalportion 524. Such a curvilinear arrangement may accommodate bending bydistributing the forces acting on the wires 552 and/or allow the wires552 to accommodate changes in path length of the catheter 510 during useor manipulation. In addition or alternatively, patterns/configurationsother than the sinusoidal pattern shown may be used to introduce excesspath length of the wires 552 as they are incorporated into thereinforcement layer 542.

In another alternative, the wires 552 may be embedded within thereinforcement layer 542 such that the wires 552 extend helically aroundthe primary lumen, e.g., similar to the auxiliary lumen shown in FIG. 2.In this manner, the wires 552 may be distributed relatively uniformlyaround the central axis 516, thereby minimizing impact of path lengthchanges when bending forces applied by the steering element 530.

In still another alternative, a wire lumen may be provided within thedistal portion 524, e.g., embedded within the reinforcement layer 542similar to the auxiliary lumens described elsewhere herein, and thewires 552 may be slidably disposed within the wire lumen.

Optionally, e.g., as shown in FIG. 11E, in an intermediate or proximalportion of the apparatus 510, the wires 552 may transition to a largecentral lumen 518 a containing other components of the apparatus 510,e.g., similar to other embodiments herein.

Although the plurality of wires 552 may be arranged such that they aredisposed immediately adjacent or against one another (or disposed withinthe wire lumen), alternatively, the wires 552 may be provided atdifferent circumferential locations relative to one another (not shown),yet still be embedded within the reinforcement layer 542. For example,the wires 552 may be spaced apart substantially evenly around theprimary lumen (e.g., offset about one hundred eighty degrees for a pairor wires, about one hundred twenty degrees for three wires, and thelike) and may be oriented in a desired configuration, e.g.,substantially axially, in a curvilinear path, or helically, whileremaining spaced apart from one another.

With additional reference to FIGS. 11A-11D, various methods may be usedfor manufacturing and/or assembling the apparatus 510 or any of theother variations described herein. For example, one or more tubularbodies including embedded wires may be produced using a substantiallycontinuous process, e.g., similar to the apparatus and methods describedelsewhere herein with reference to FIGS. 4A-4C. For example, the methodsmay be used to make a relatively short tubular body corresponding to asingle catheter, or may be used to make a relatively long tubular bodythat may be subsequently separated into individual catheter bodies. Thecomposition of the components for the apparatus 510 and construction andoperation of an apparatus for making the apparatus 510 may be similar tothose described with reference to FIGS. 4A-4C elsewhere herein, and socomponents of the apparatus 50 are referenced below where applicable.

Generally, similar to the apparatus 50 shown in FIG. 4A, an exemplarymanufacturing apparatus for making the apparatus 510 may include one ormore sources 52, 54 of mandrels 2 and/or liners 4 (e.g., to form theprimary lumen and one or more auxiliary lumens), a source of wires(e.g., one or more reels carrying individual or a plurality of wires,not shown), a guide 60, a source 70 of reinforcement members 6, a drivemechanism 80, and, optionally, a source 90 of jacket material 7. Theapparatus 50 may allow for substantially continuous fabrication oftubular bodies, e.g., wrapping a liner material 4 a around a primarymandrel 2 a, positioning an auxiliary mandrel 2 b (with optional linermaterial) adjacent the primary mandrel 2 a, positioning the set of wiresadjacent the primary mandrel 2 a, and braiding a plurality ofreinforcement members 4 around the mandrels 2 and wires. In analternative embodiment, where the wires are provided within a lumen, anadditional mandrel source (with optional liner, both not shown) may beprovided instead of the source of wires, and the additional mandrel maybe positioned adjacent the primary mandrel 2 a, e.g., at a desiredcircumferential location, such as aligned with the intended neutral axisof the final tubular device. For example, the lumen (or wires) may beoffset from the auxiliary mandrel 2 b about ninety degrees (90°)circumferentially around the primary mandrel 2 a.

During operation, liner material 4 a may be wrapped at least partiallyaround the primary mandrel 2 a, e.g., as the primary mandrel 2 a andliner material 4 a are fed through the guide 60. The auxiliary mandrel 2a and wires may be positioned adjacent the liner-wrapped primary mandrel2 a, and reinforcement members 6 may be wrapped around the mandrels 2and wires, e.g., upon exiting the guide 60 to braid the auxiliarymandrel 2 b and wires within the reinforcement members 6.

In the exemplary embodiment shown in FIG. 4B, the reinforcement source70 may include an arrangement of horn gears 72, e.g., mounted in agenerally circular configuration around the guide 60, for example, to abase or other support structure 76. One of the horn gears 72 a mayinclude a passage 73 a therethrough, and the auxiliary mandrel 2 b maypass through the passage 73 a, e.g., from the source 52 b towards theprimary mandrel 2 a where it exits the guide 60. Similarly, a set ofwires may be directed through a central passage in another of the horngears (not shown) towards the primary mandrel 2 a where it exits theguide 60 (or individual wires may be directed through separate centralpassages towards the primary mandrel 2 a). Optionally, if additionalauxiliary lumens or separate wires are to be provided in the tubularbodies 8, one or more additional horn gears may also include suchpassage(s) for guiding corresponding auxiliary mandrel(s) and/or wire(s)therethrough.

As a result of this process, some reinforcement members 6 pass betweenthe primary mandrel 2 a and the wires, some reinforcement members 6 passbetween the primary mandrel 2 a and the auxiliary mandrel 2 b, and somereinforcement members 6 surround both the primary mandrel 2 a and one orboth of the auxiliary mandrel 2 b and the wires. Thus, as can be seen inFIGS. 11A-11D, the wires 552 may be braided/incorporated into thereinforcement members 6 of the reinforcement layer 542, similar to theauxiliary mandrel 2 b as described in other embodiments herein. Such aconfiguration may minimize the impact of the wires 552 on the outerprofile of the resulting tubular body, ensure security of the wires 552,and/or increase ease of incorporation of the wires 552 into the tubularbody. In addition, the reinforcement members 6 may constrain the wires552, e.g., to minimize the wires interfering with subsequent processingof the tubular body. The reinforcement members 6 may include variousmetal alloys, plastic filaments, glass fibers and the like, as is knownin the art. The profile of reinforcement members 6 may be substantiallyround, rectangular, and or have other cross-sectional profile as is alsoknown in the art. The size of the reinforcement members 6 may range fromabout 0.0005″ to 0.010″ and more than one size may be used. In anexemplary embodiment, the reinforcement members 6 may be stainless steelround wire, e.g., to avoid damage to insulation on the wires 552. In analternative embodiment (not shown), the reinforcement members 6 passingunder the wires 552 may comprise a rectangular cross section while thereinforcement members 6 passing over the wires 552 may comprise a roundcross-section, e.g. to reduce potential for damage to the wires 552 ortheir insulation.

The apparatus 50 may be operated such that the wires extend in acurvilinear path along the length of the primary mandrel, as shown inFIG. 11A. For example, a guide (not shown) may be provided adjacent theguide 60 that oscillates or otherwise moves to place the wires generallyaxially but in sinusoidal or other pattern of increased path lengthagainst the primary mandrel. Alternatively, the wires may be fedintermittently at a rate faster than the braiding feed rate, e.g. toincorporate excess path length of the wire into the braided assembly.Further alternatively, if desired, the wires may be wound helicallyaround the primary mandrel, e.g., similar to the method describedelsewhere herein with reference to FIG. 2, or may be directedsubstantially axially (e.g., as shown in FIG. 10).

In addition, the apparatus and methods herein may facilitatetransitioning the wires at one or both ends of a tubular device. Forexample, as shown in FIG. 11A, three wires 552 are shown captured withinthe reinforcement members 6. The wires may extend together along theprimary mandrel (e.g., from an intermediate region or the proximal end)until a first location where an electrode or sensing element is to beprovided on the apparatus 510. A first wire (or set of wires), e.g.,corresponding to wire 552 a in FIG. 11A, may be disengaged from thebraider such that the first wire remains entirely outside thereinforcement members 6.

For example, after a desired portion of the three wires 552 has beenbraided to the primary mandrel 2 a by the reinforcement members 6, thefirst wire may be cut or otherwise separated from the horn gear and/orotherwise positioned outside the braiding point. Thus, as reinforcementmembers 6 continue to be braided around the primary mandrel 2 a, thefirst wire 552 a remains outside the braid, and only the second andthird wires 552 b, 552 c are captured by the braid, as can be seen inFIG. 11B. Similarly, when a second electrode location is reached, thesecond wire may be disengaged from the braider such that the second wireremains entirely outside the reinforcement members 6. Further braidingcaptures only the third wire 552 c, as shown in FIG. 11C. When a thirdelectrode location is reached, the third wire may be disengaged from thebraider such that the third wire remains entirely outside thereinforcement members 6. Any further desired braiding may then beperformed on the primary and auxiliary mandrels 2. Thus, thereafter, allof the wires 552 remain outside the reinforcement members 6.

Thereafter, one or more layers of jacket material 7 may be appliedaround the reinforcement-wrapped mandrels 2. For example, with referenceto FIGS. 4A-4C, a co-extruder, laminator, or other applicator may beprovided that applies melted, uncured, and/or otherwise raw jacketmaterial 7, e.g., from a hopper or other container (not shown), or rollssheets of jacket material 7 may be wrapped around the reinforcementmembers 43 and mandrels 2.

Optionally, a length of each wire 552 may be maintained to at leastpartially form an electrode or sensing element. For example, as shown inFIGS. 11A-11C, the free end of each wire 552 may have sufficient length,e.g., between about one and ten centimeters (1-10 cm), such that thefree end may be wound one or more times around the assembly, e.g., todefine coils 554. The coils 554 may be created before applying thejacket material 7 such that the coils 554 are embedded in the jacketmaterial (not shown in FIGS. 11A-11C). Alternatively, the coils 554 maybe wrapped around the outer jacket 524, e.g., within annular groovesformed in the outer jacket 524 or simply around the outer surface (notshown). In this alternative, the coils 554 may be secured to the outerjacket 524, e.g., by interference fit, bonding with adhesive, and thelike. Optionally, an insulating layer may be at least partially removedfrom the coils 554 to electrically expose the coils 554 for sensingand/or energy delivery. Alternatively, an insulating layer may be atleast partially applied over the coils 554 to electrically isolate themand/or protect the coils 554 from corrosion or other undesired exposure.

Optionally, if the resulting tubular device corresponds to multiplecatheter bodies, the tubular device may be separated into individualcatheter bodies, each having a desired number of coils 554 and wires552, e.g., three as shown in FIGS. 9 and 11A-11C. Alternatively,individual catheter bodies may be formed using the apparatus 50, similarto other embodiments herein.

After (or optionally before) separating the tubular device intoindividual catheters, electrodes may be built on the outer surfaces atthe locations of wire exit and/or coils 544. Optionally, at least aportion of the insulation on the free end of each wire 552 may beremoved, if desired, to facilitate electrically coupling the wire 552 toother components of the electrode 550. For example, if the jacketmaterial has been applied, a portion of the jacket material overlyingeach coil 554 may be removed, and then the insulation on the outersurface of each coil 554 may be removed such that the coil 554 remainselectrically isolated from the reinforcement members 6 but anelectrically conductive contact surface is provided.

Then, as shown in FIG. 11D, a biocompatible electrically conductivepolymer, adhesive, epoxy, solder, and/or other material 556 may bondedor otherwise conductively attached to the conductive wire 556 where theinsulation and jacket material has been removed. As shown in FIG. 9, theresulting electrodes 550 may have a relatively small surface area on theouter surface of the distal portion 524 of the resulting apparatus 510.For example, the resulting electrodes 550 may extend not more thantwenty percent (20%) or not more than ten percent (10%) around thecircumference of the distal portion 524, which may minimize impact ofthe electrodes 550 on the bending properties of the distal portion 524.Alternatively, ring, coil, or other annular electrodes may be placedaround the apparatus 510, e.g., over respective coils 556. Theelectrodes may be electrically coupled to the coils 556, e.g., bysoldering, using conductive adhesive, and the like. In a furtheralternative, the coils 554 may provide sufficient inductive propertiesthat no additional electrode components may be needed.

In alternative embodiments, the coil 554 may be formed after applyingthe jacket material or the electrode material 556 may be bonded to thecoil 554 or wire termination before applying the jacket material. Forexample, in some embodiments, the electrodes may not need to contacttissue or fluids within the patient's body and so may remain within theouter jacket.

Optionally, other components may be added to the individual tubulardevices, as desired for the particular application. For example, for asteerable catheter, a steering element 530 may be inserted through theauxiliary lumen created when the auxiliary mandrel 2 b is removed. In analternative embodiment, the auxiliary mandrel 2 b may remain within thetubular device to provide the steering element, e.g., if the frictionbetween the outer surface of the auxiliary mandrel 2 b and the liner orother material defining the auxiliary lumen are relatively low. A tip orother component (not shown) may be attached to a distal end of thetubular device, e.g., after attaching one end of the steering element530 to the tip. The other end of the steering element 530 may be coupledto an actuator of a handle attached to a proximal end of the tubulardevice (not shown), e.g., similar to embodiments described elsewhereherein.

The resulting apparatus 510 may be used for a variety of applications.For example, the apparatus 510 may be a guide sheath that may be used aspart of an impedance and/or magnetic/inductance-based position sensingsystem to assist with locating one or more secondary devices, such as anablation catheter (not shown), within a patient's body. The electrodesmay be positioned at predetermined locations in order to define thecurve of a deflectable distal segment, e.g. 2, 3, or more electrodes maybe placed at predetermined locations along a known path length such thattheir relative position to one another may be used to define the arc ofa deflected segment as further described below. Additionally oralternatively one or more proximal electrodes may be included, e.g. toserve as a central terminal, e.g. when positioned in the inferior venacava or other central vessel or location within the body. Moreover,electrodes may be used for sensing electrograms, providing signals todetermine position and/or for energy delivery. The system may include acontroller and/or other sensor or processor (not shown) coupled to theelectrodes 550 via the wires 552 (and a connector and/or cables, notshown) on the proximal end of the apparatus 510. In addition, the systemmay include an external detector (also not shown) also coupled to thecontroller, which may be positioned adjacent and external to thepatient's body to activate and/or detect the electrodes 550. Thus, thesystem may use the electrodes 550 to “sense” the position and/ororientation of the distal portion 524 within a patient's body.Alternatively, the apparatus 510 may be an ablation catheter that usesthe electrodes 550 for mapping and/or for delivering electrical energyto tissue.

With additional reference to FIG. 9, the electrodes 550 may be spaced ina desired arrangement based on the settings of the controller and/orother equipment (not shown) coupled to the electrodes 550 (e.g., via aconnector on the proximal end of the apparatus 510, as describedelsewhere herein). In an exemplary embodiment, the first electrode 550 amay be located at the beginning of the steerable distal portion 524, thethird electrode 550 c may be located at the end of the steerable portion524, and the second electrode 550 b may be located half way along thesteerable portion 524. When the distal portion is deflected within apatient's body, the controller or processor may interpolate the shape ofthe resulting deflection curve based on the positions of the electrodes,which can be used to determine the shape and location of the distalportion 524. Given that the electrodes 550 are intended simply forimpedance-based sensing, the electrodes may be relatively small and canbe positioned simply on one side of the distal portion 524, e.g.,compared to ablation electrodes.

The foregoing disclosure of the exemplary embodiments has been presentedfor purposes of illustration and description. It is not intended to beexhaustive or to limit the invention to the precise forms disclosed.Many variations and modifications of the embodiments described hereinwill be apparent to one of ordinary skill in the art in light of theabove disclosure.

Further, in describing representative embodiments, the specification mayhave presented the method and/or process as a particular sequence ofsteps. However, to the extent that the method or process does not relyon the particular order of steps set forth herein, the method or processshould not be limited to the particular sequence of steps described. Asone of ordinary skill in the art would appreciate, other sequences ofsteps may be possible. Therefore, the particular order of the steps setforth in the specification should not be construed as limitations on theclaims.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

We claim:
 1. A tubular device for a catheter or sheath, the tubulardevice comprising a proximal end and a distal end sized for introductioninto a patient's body, the tubular device comprising: a primary lumenextending between the proximal and distal ends; one or more elongateconducting elements extending at least partially between the proximaland distal ends adjacent the primary lumen; a plurality of reinforcementmembers braided together around the primary lumen such that thereinforcement members pass over and under one another according to apredetermined arrangement, the reinforcement members comprising windingsextending helically around the primary lumen between the proximal anddistal ends, at least some of the windings passing between the primarylumen and the one or more conducting elements and at least some of thewindings surrounding both the primary lumen and the one or moreconducting elements; one or more layers comprising an outer jacketsurrounding the plurality of reinforcement members; and one or moresensing elements on a distal portion of the tubular device electricallycoupled to the one or more conducting elements, wherein the one or moreconducting elements transition to the primary lumen in an intermediateor proximal portion of the tubular device.
 2. The tubular device ofclaim 1, wherein the one or more conducting elements comprise aplurality of wires.
 3. The tubular device of claim 2, wherein theplurality of wires are electrically insulated.
 4. The tubular device ofclaim 2, wherein the one or more sensing elements comprise a pluralityof electrodes spaced apart from one another on the distal portion,wherein a first electrode of the plurality of electrodes is coupled to afirst wire of the plurality of wires, and wherein a second electrode ofthe plurality of electrodes is coupled to a second wire of the pluralityof wires.
 5. The tubular device of claim 1, wherein the one or moreconducting elements are embedded directly in the one or more layers. 6.The tubular device of claim 1, wherein the one or more conductingelements are disposed within a wire lumen extending at least partiallybetween the proximal and distal ends.
 7. The tubular device of claim 1,wherein the one or more conducting elements extend substantiallyparallel to a longitudinal axis of the tubular device at least partiallybetween the proximal and distal ends.
 8. The tubular device of claim 1,wherein the one or more conducting elements extend along a curvilinearpath at least partially between the proximal and distal ends.
 9. Thetubular device of claim 8, wherein the curvilinear path is generallysinusoidal.
 10. The tubular device of claim 1, wherein the one or moreconducting elements extend helically around the primary lumen at leastpartially between the proximal and distal ends.
 11. The tubular deviceof claim 1, wherein the one or more sensing elements comprise one ormore electrodes mounted on the distal portion.
 12. A tubular device fora catheter or sheath, the tubular device comprising a proximal end and adistal end sized for introduction into a patient's body, the tubulardevice comprising: a primary lumen extending between the proximal anddistal ends; one or more elongate conducting elements extending at leastpartially between the proximal and distal ends adjacent the primarylumen; a plurality of reinforcement members braided together around theprimary lumen such that the reinforcement members pass over and underone another according to a predetermined arrangement, the reinforcementmembers comprising windings extending helically around the primary lumenbetween the proximal and distal ends, at least some of the windingspassing between the primary lumen and the one or more conductingelements and at least some of the windings surrounding both the primarylumen and the one or more conducting elements; one or more layerscomprising an outer jacket surrounding the plurality of reinforcementmembers; and one or more sensing elements on a distal portion of thetubular device electrically coupled to the one or more conductingelements, wherein the one or more conducting elements extend helicallyaround the primary lumen at least partially between the proximal anddistal ends proximal to the distal portion, and wherein the one or moreconducting elements transition outside the reinforcement members in thedistal portion, wherein the one or more conducting elements transitionto the primary lumen in an intermediate or proximal portion of thetubular device.
 13. The tubular device of claim 12, wherein the one ormore conducting elements extend along the distal portion in acurvilinear arrangement.
 14. The tubular device of claim 13, wherein thecurvilinear arrangement is generally sinusoidal such that the one ormore conducting elements extend along the distal portion in a sinusoidalpattern immediately adjacent one another.
 15. The tubular device ofclaim 14, wherein the one or more conducting elements are substantiallycentered on a neutral axis of the distal portion.